A Prospective Study of Treating Duodenal Papillary Sphincter in Different Ways During ERCP

Sponsor

Zhujiang Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03416205

Collaborator

Nanfang Hospital of Southern Medical University (Other)

450

Enrollment

Location

Arms

49.4

Anticipated Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Endoscopic retrograde cholangiopancreatography (ERCP) is commonly performed to remove bile duct stones.Endoscopic sphincterotomy (EST), endoscopic papillary balloon dilation (EPBD), and endoscopic sphincterotomy plus balloon dilation (sEST+EPBD) are 3 methods used to enlarge the papillary orifice, but their efficacy and safety remains controversial. This study aimed to compare these methods for treating common bile duct (CBD) stones.

Condition or Disease	Intervention/Treatment	Phase
ERCP	Device: Erbao electric knife Device: Three-cavity incision knife Device: Columnar expansion balloon	N/A

Detailed Description

Investigators first divided the patients with different sizes of common bile duct stones into two groups. The bile duct stone diameter of group A is less than 1.0cm while group B is more than 1.0cm and less than 1.5cm. Each group compared Endoscopic sphincterotomy (EST), endoscopic papillary balloon dilation (EPBD), and endoscopic sphincterotomy plus balloon dilation (sEST+EPBD) in ERCP. Through the postoperative comparison of relevant inspection test indicators, the recovery of patients, whether the occurrence of complications, including infection,bleeding,pancreatitis,perforation , and 1 year stone recurrence rate,Investigators assess the advantages and disadvantages in three different strategies in different sizes of common bile duct stones , and finally get a relatively objective evaluation to guide our daily ERCP work on the choice of duodenal papillary sphincter treatment strategy.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

450 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

A Prospective Study of Treating Duodenal Papillary Sphincter in Different Ways During ERCP: Comparison of EST, EPBD, and sEST+EPBD in Endoscopic Choledocholithiasis Treatment.

Actual Study Start Date :

Jul 20, 2017

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EST EST is an operation using the Erbao electric knife and Three-cavity incision knife to make a large incision to the duodenal nipples，and the incision scope is the nipple mouth uplift length of 4/5. It has been used since 1974. The technique is intuitive and intact. However, EST cut too small to achieve the purpose of treatment and will affect the next step, and if the incision is too large it may be easier to occur gastrointestinal perforation and bleeding.The EST will also damage the anatomy of the Oddi sphincter structure,which causes bacterial reflux to the bile duct, the recurrence of CBD.Some surgeons prefer it because it's postoperative pancreatitis rate is lower and it may be easier to find the lesion position if bleeding or perforation occurs.	Device: Erbao electric knife Erbao electric knife is used to cut the Duodenal sphincter Device: Three-cavity incision knife Three-cavity incision knife is used to cut the Duodenal sphincter
Experimental: EPBD EPBD is an operation using the Columnar expansion balloon to expand duodenal to achieve the purpose of using the basket and other instruments to take stone out. Balloon expansion may retain part of the sphincter not destroyed, and basically retain the normal physiological function of the nipple sphincter.Thus it may reduce the risk of recurrence of stones and bacterial reflux. However,the postoperative pancreatitis rate is high(4.8% -19.5% ), and nipple sphincter tear is uncontrollable in EPBD.If the digestive tract perforation or bleeding occur after EPBD,it is hard to accurately find the lesion position.Some surgeons prefer it for it's lower bleeding and perforation rate.	Device: Columnar expansion balloon Columnar expansion balloon is used to expand the the Duodenal sphincter
Experimental: sEST+EPBD sEST+EPBD is an operation combining EST and EPBD. Investigators use the Erbao electric knife and Three-cavity incision knife to make a small incision to the duodenal nipples, and the incision length is less than 5mm while the incision scope is less than the nipple mouth uplift length of 1/2. Then, Investigators match the appropriate Columnar expansion balloon according to the diameter of the common bile duct and gradually expand the duodenal nipples.This method allows the nipple sphincter to be cut in a small range, then the balloon can guide the direction of the nipple sphincter tearing after the expansion , so that the digestive tract bleeding, perforation may be smaller and more controllable. Besides,it may reduce postoperative pancreatitis rate and the recurrence rate of stones.	Device: Erbao electric knife Erbao electric knife is used to cut the Duodenal sphincter Device: Three-cavity incision knife Three-cavity incision knife is used to cut the Duodenal sphincter Device: Columnar expansion balloon Columnar expansion balloon is used to expand the the Duodenal sphincter

Arm

Intervention/Treatment

Experimental: EST

EST is an operation using the Erbao electric knife and Three-cavity incision knife to make a large incision to the duodenal nipples，and the incision scope is the nipple mouth uplift length of 4/5. It has been used since 1974. The technique is intuitive and intact. However, EST cut too small to achieve the purpose of treatment and will affect the next step, and if the incision is too large it may be easier to occur gastrointestinal perforation and bleeding.The EST will also damage the anatomy of the Oddi sphincter structure,which causes bacterial reflux to the bile duct, the recurrence of CBD.Some surgeons prefer it because it's postoperative pancreatitis rate is lower and it may be easier to find the lesion position if bleeding or perforation occurs.

Device: Erbao electric knife

Erbao electric knife is used to cut the Duodenal sphincter

Device: Three-cavity incision knife

Three-cavity incision knife is used to cut the Duodenal sphincter

Experimental: EPBD

EPBD is an operation using the Columnar expansion balloon to expand duodenal to achieve the purpose of using the basket and other instruments to take stone out. Balloon expansion may retain part of the sphincter not destroyed, and basically retain the normal physiological function of the nipple sphincter.Thus it may reduce the risk of recurrence of stones and bacterial reflux. However,the postoperative pancreatitis rate is high(4.8% -19.5% ), and nipple sphincter tear is uncontrollable in EPBD.If the digestive tract perforation or bleeding occur after EPBD,it is hard to accurately find the lesion position.Some surgeons prefer it for it's lower bleeding and perforation rate.

Device: Columnar expansion balloon

Columnar expansion balloon is used to expand the the Duodenal sphincter

Experimental: sEST+EPBD

sEST+EPBD is an operation combining EST and EPBD. Investigators use the Erbao electric knife and Three-cavity incision knife to make a small incision to the duodenal nipples, and the incision length is less than 5mm while the incision scope is less than the nipple mouth uplift length of 1/2. Then, Investigators match the appropriate Columnar expansion balloon according to the diameter of the common bile duct and gradually expand the duodenal nipples.This method allows the nipple sphincter to be cut in a small range, then the balloon can guide the direction of the nipple sphincter tearing after the expansion , so that the digestive tract bleeding, perforation may be smaller and more controllable. Besides,it may reduce postoperative pancreatitis rate and the recurrence rate of stones.

Device: Erbao electric knife

Erbao electric knife is used to cut the Duodenal sphincter

Device: Three-cavity incision knife

Three-cavity incision knife is used to cut the Duodenal sphincter

Device: Columnar expansion balloon

Columnar expansion balloon is used to expand the the Duodenal sphincter

Outcome Measures

Primary Outcome Measures

the incidence of composite events of infection, hemorrhage, perforation, pancreatitis [3 and 24 hours after the ERCP]
Investigators comprehensively assess whether the hemorrhage, perforation, pancreatitis and other complications of retrograde cholangiopancreatography (ERCP) happen or not by clinical sympton and blood index 1 day after the ERCP. The blood index includes CRP, amylase,lipase,leukocyte,red blood cell,hemoglobin.Besides,CT will be done if necessary.Finally investigators use statistical method to analyse the incidence of composite events of infection, hemorrhage, perforation, pancreatitis.

Secondary Outcome Measures

Recurrence rate of bile duct stones [1 year after the ERCP.]
One year after the ERCP,the participants will have a CT scan to find out whether the bile duct stones recur again.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 20-80 years old
CT or MRCP diagnose the patients with Common bile duct stones
The diameter of the stone is less than or equal to 1.5cm
Patients with the indications for ERCP
Patients and their families agree to participate in the trial

Exclusion Criteria:

Stones are too large (> 1.5cm)
A history of gastrointestinal surgery
ERCP and EST or EPBD surgery history
Patients generally poor, total bilirubin> 200umol / L or PT time extension> 3s
Patients with mental illness or other serious heart and lung disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhujiang Hospital	Guangzhou	Guangdong	China	510282

Sponsors and Collaborators

Zhujiang Hospital
Nanfang Hospital of Southern Medical University

Investigators

Principal Investigator: Changhui Yu, Doctor, Zhujiang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zhujiang Hospital

ClinicalTrials.gov Identifier:

NCT03416205

Other Study ID Numbers:

2017-XHNK-001

First Posted:

Jan 31, 2018

Last Update Posted:

Mar 19, 2018

Last Verified:

May 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 19, 2018